Myopia Control With Orthokeratology Contact Lenses in Spain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Menicon Co., Ltd.
- Enrollment
- 69
- Primary Endpoint
- Axial length
Study Overview
Brief Summary
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.
Detailed Description
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be 6 to 12 years of age, both ages inclusive
- •A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
- •Neophyte contact lens wearer
- •Be successfully fitted with spectacles or orthokeratology contact lenses
- •Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
- •Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
- •White European ethnicity
Exclusion Criteria
- •Systemic or ocular disease affecting ocular health
- •Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
- •Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
- •CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
- •Aphakic, amblyopic, and atopic individuals
- •Refractive astigmatism ≥ ½ spherical refraction
- •Previous contact lens wear
Outcomes
Primary Outcomes
Axial length
Time Frame: Two years
To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.
Secondary Outcomes
- Patient-reported outcomes(Two years)
- Adverse events(Two years)